Evaluation of Insulin Glulisine (GP40321) Compared to Insulin Glulisine (Apidra® SoloStar®) in Type 1 Diabetes Mellitus Patients

Summary

The goal of this clinical trial is to demonstrate the non-inferior immunogenicity of GP40321 compared to Apidra® SoloStar® at a concentration of 100 U/mL in type 1 diabetes mellitus patients. The main questions it aims to answer are: * What is the immunogenicity of GP40321 and Apidra® SoloStar®? * What are the efficacy and safety of GP40321 and Apidra® SoloStar®? Researchers will compare the immunogenicity, efficacy and safety parameters of GP40321 and Apidra® SoloStar®. Participants will: • Visit the clinic 9 times: once for screening, 3 times during dose titration (plus 2 telephone contacts) and 5 times during the stable dose treatment period.

Timeline

Start

2023-04-14

Primary completion

2023-11-28

Completion

2023-11-28

Publications

• Drai R, Galstyan G, Karonova T, Protsenko E, Parfenova T, Arefeva A, Matvienko I, Iliushchenko D, Makarenko I. Immunogenicity, efficacy and safety of a biosimilar insulin glulisine compared with originator in adults with type 1 diabetes mellitus: A phase III randomised clinical trial. Diabetes Obes Metab. 2026 Mar;28(3):1791-1799. doi: 10.1111/dom.70360. Epub 2025 Dec 9.

Drugs

Indications